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Posts Tagged ‘US’

EU-US Mutual Recognition Agreement for inspections

May 8, 2019


With the Mutual Recognition Agreement between Europe and the US, inspections are to be mutually recognised in the future. The FDA’s approval of the EU Member States proceeds successively. Two more countries have recently been approved: Bulgaria and Cyprus. That makes 24 approved EU states so far. There are 4 countries left: Germany, the Netherlands, Luxembourg and Slovakia. By 15 July, 2019 though, all authorities and countries are supposed to have been reviewed and approved. Regular updates may be found in a question and answer document on the EMA’s website.

Update of MRA between EU and US

April 14, 2017


The European Commission and the United States Food and Drug Administration (FDA) have updated the EU-US 1998 Mutual Recognition Agreement (MRA). According to this amendment, the EU and US regulatory authorities now mutually recognize inspections of pharmaceutical manufacturing facilities.

The aim of this MRA is to avoid the duplication of inspections, to lower inspection costs and to enable regulators to devote more resources to other parts of the world where there may be greater risk.

The MRA states that by November 2017, FDA must have assessed authorities in eight EU countries and that FDA’s assessment of all of the EU national agencies has to be completed by July 15th 2019.